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510(k) Data Aggregation
K Number
K241995Device Name
HyperFlex Bunion Correction System
Manufacturer
Date Cleared
2024-11-26
(140 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
FootBridge Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FootBridge Medical HyperFlex™ Bunion Correction System is intended for use in reconstruction (correction) of the hallux valgus deformity by holding the reduction of the 1st metatarsal intermetatarsal (IM) angle in adults and pediatric patients aged ≥13 years in which growth plates have fused.
Device Description
The FootBridge Medical HyperFlex™ Bunion Correction System is an implantable device and accompanying instrumentation used to treat a hallux valgus deformity (bunion). It includes components that attach to the 1st and 2nd metatarsals which are joined by a suture. The system reduces the IM angle between the 1st and 2nd metatarsal without restricting range of motion in the sagittal plane. The implant will be offered in several sizes to fit the anatomical needs of the patient population.
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